Retainer for a combined surgical needle-suture device possessing a needle shield with needle tip stop feature

ABSTRACT

A retainer for a combined surgical needle-suture device possesses a needle shield featuring a stop element which prevents the tip of the needle from puncturing the package in which the retainer is held.

This is a divisional of U.S. application Ser. No. 08/098,742 filed Jul.28, 1993, now U.S. Pat. No. 5,353,922 which is a continuation of U.S.application Ser. No. 07/816,101 filed Jan. 2, 1992 now abandoned.

BACKGROUND OF THE INVENTION

This invention relates to a retainer for a combined surgicalneedle-suture device, also commonly referred to as an "armed suture" orsimply a "suture" as part of a suture package. Retainers for sutures areknown from, inter alia, U.S. Pat. Nos. 3,363,751; 3,444,944; 3,613,878;3,759,376; 3,857,484; 3,939,969; 3,951,261; 3,972,418; 3,985,277;4,063,638; 4,089,409; 4,120,395; 4,135,623; 4,192,420; 4,249,656;4,253,563; 4,284,194; 4,406,363; 4,412,614; 4,413,727; 4,427,109;4,483,437; 4,491,218; 4,496,045; 4,533,041; 4,555,016; 4,572,363;4,574,948; 4,574,957; 4,615,435; 4,708,241; 4,813,537; 4,884,681;4,887,710; 4,896,767; 4,961,498; and, 4,967,902.

As an essential component of a suture package, the suture retainershould possess good storing qualities, provide safety in handling andpermit ready access to, and removal of, the stored sutures.

SUMMARY OF THE INVENTION

By way of meeting the foregoing criteria, there is provided inaccordance with this invention a retainer for a combined surgicalneedle-suture device, the retainer comprising:

a) a base panel for retaining at least one surgical needle of a combinedsurgical needle-suture device; and,

b) a needle shield mounted upon the base panel, the needle shieldpossessing a stop for retaining the tip of the needle.

The stop feature of the needle shield effectively prevents accidentalpuncture by a stored needle and permits rapid access and removal of anarmed suture when desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are perspective views of embodiments of a needle shield inaccordance with the present invention;

FIGS. 3 and 4 are perspective views of the obverse and reverse sides,respectively, of an armed suture retainer card with the needle shield ofFIG. 1 mounted thereon;

FIG. 5 is a top plan view of a suture package, including its outerbreather package, suitable for packaging the armed suture retainer ofFIGS. 3 and 4; and,

FIG. 6 is a top plan view of the suture package of FIG. 5 removed fromthe breather package and opened for partially exposure of its armedsuture contents.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIGS. 1 and 2, needle shields 10 and 10' are each fabricatedfrom a suitably stiff material, preferably a transparent thermoplasticresin such as polyethylene terephthalate. The needle shields areconveniently manufactured from sheets of thermoplastic resin by suchknown and conventional processes as thermoforming.

Needle shield 10 possesses top and bottom edges 11 and 12, respectively,and flanged parallel lateral edges 13 and 14, respectively, by which theneedle shield grips side edges 31 and 32 of retainer base panel 30 asshown in FIGS. 3 and 4. An arcuate stop, or wall, 16 projecting upwardlyfrom surface 15 of needle shield 10 retains the sharp tips of needlecomponents 18 (as shown in FIG. 3) preventing the tip from causingaccidental puncture of front panel 43 of peel-open suture package 40(shown in FIGS. 5 and 6). Advantageously, stop 16 continues a shortdistance up lateral edge 13 to provide additional security againstaccidental puncture. By way of maintaining needle components 18 in aneat array upon surface 15 of needle shield 10, the surface is providedwith a series of cuts defining tabs 17 which, when displaced upwardlyfrom surface 15, provide elements for securing individual needles 18 inplace. Needle securing means other than tabs 17 can, of course, beutilized, e.g., a series of approximately parallel "bumps: with a needlesnap-fitted therebetween (not shown).

Needle shield 10', like needle shield 10, possesses flanged lateraledges 13' and 14' by which the needle shield grips the side edges of anarmed suture retainer panel. Stop 16' is an integral element of pocket19 and like stop 16 of needle shield 10, retains the tip of a needlethereby preventing accidental puncture of the armed suture package.However, unlike needle shield 10 in which the needles lie upon surface15 of the shield, in needle shield 10' the stored needles are retainedwithin pocket 19, i.e., beneath surface 15' of the shield.

As shown in FIGS. 3 and 4 and in dotted outline in FIG. 6, the generalappearance of retainer base panel 30 is that of a flat, relatively stiffpanel whose longest sides 31 and 32 are parallel to each other to permitneedle shield 10 or 10' to be slid onto the retainer during thepackaging operation. Retainer 30 can be constructed from any of severaldifferent types of materials including various kinds of plastics,paper-foil laminate, etc. Retainer base panel 30 is more fullydescribed, together with peel-open foil package 40 of FIGS. 5 and 6 foraccommodating the loaded retainer, U.S. Pat. No. 5,154,283, the contentsof which are incorporated by reference herein. A similar retainer basepanel which is also suitable for use herein is described in U.S. Pat.No. 5,129,511, the contents of which are incorporated by referenceherein.

As shown in FIGS. 3 and 4, needle shield 10 has been mounted in place bybeing slid onto retainer base panel 30 in the direction indicated by thearrow. A number of armed sutures are secured in place upon retainer basepanel 30, their curved needle components 18 lying flat upon a portion ofobverse side 33 of the base panel and a portion of surface 15 of needleshield 10 with their suture components 20 extending through triangularshaped aperture 34 to reverse side 35 of the base panel where theyoccupy coiled passageway 36. The sutures can be drawn into coiledpassageway 36 by applying a vacuum through orifice 37 positioned at thefar end of the passageway. Under the influence of the vacuum, thesutures quickly occupy the passageway.

The fully loaded armed suture retainer of FIGS. 3 and 4 is convenientlypackaged in peel-open metal foil suture package 40 of FIG. 5 shown inits outer breather package 50 following sterilization and sealing.Suture package 40 comprises an envelope 41 made up of front panel 42joined to a rear panel (not shown) along common edges 44 employing anyknown and conventional adhesive. Peelable closure flap 45 completespackage 40 and is advantageously provided with a knurled or embossedtrapezoidally configured edge 46 to facilitate gripping. The material ofconstruction of the front and rear panels and the closure flap is onewhich prevents or greatly impedes the transmission of moisturetherethrough. In the embodiment shown, the walls and the closure flapare of laminate construction of a known type in which an aluminum foilis faced on its interior side with a polyolefin film such aspolyethylene film. The laminate can vary in thickness from about 3 toabout 5 mils and preferably from about 3.5 to about 4.5 mils.

Retainer base panel 30 is provided with an extension panel 38 which isadhesively secured to the undersurface of closure flap 45 such that whenthe closure flap is pulled open, it will not readily completely separatefrom package 40 where it might otherwise litter the operating area. Toremove an armed suture from opened suture package 30, the shank of aneedle is grasped by a needle gripper and pulled away from the package,usually in a direction which is more or less in the plane of thepackage.

Outer breather package 50 (FIG. 5) can be of known and conventionalstructure in which a gas-impermeable clear plastic sheet is heat sealedaround its top and bottom edges 51 and 52 and its longitudinal edges 53and 54 to a gas-permeable but sterile-secure backing sheet such as a webof spun-bonded polyolefin fiber, e.g., DuPont's Tyvek. In an improvementin this type of breather pouch which is especially suitable for use withthe present invention, the fibrous backing sheet is provided with astrip of release agent, e.g., of a water-based adhesive which dries to anon-tacky finish, along its longitudinal edges which effectivelyeliminates the possibility of fiber-pull in the sheet when the clearplastic sheet is stripped away. Thus, as the top seal is peeled apart,the release agent along the longitudinal edges facilitates opening ofthe package and substantially eliminates the possibility of fiber-pullalong the longitudinal edges by providing a pull-force which issubstantially less than the force required to separate the fibers in thebacking sheet from themselves. Also, as a result of the application ofthe release agent to the longitudinal edges, the pull force at the topand bottom seals required to separate the plastic layer from the fibrousbacking sheet is slightly greater than the pull force required toseparate the two layers at the side edges. Thus, after the initial pullseparates the sheets at the top seal, it is easier to open the rest ofthe package by pulling the sheets apart since the force required toseparate the sheets at the longitudinal edges is less than the forcerequired to separate the initial top heat seal.

The improved breather pouch can be manufactured on an apparatus whichfeeds a web of fibrous backing material, e.g., Tyvek, having at leasttwo continuous longitudinally directed strips of release agent materialapplied thereon at regular intervals starting at the first edge of theweb and terminating at the second longitudinal edge. The apparatus feedsthe web of Tyvek material and a web of plastic material, preferablypolyethylene, to a position to enclose suture packages placed in rowsbetween the plastic and Tyvek layers. This assembly is then fed to aheat seal device which simultaneously provides transverse andlongitudinal heat seals to seal the suture packages between the twolayers. Preferably, the plastic web is vacuum formed to provide recessesor pockets to accept the suture packages thereon. The Tyvek thenoverlays the plastic and suture packages and the heat seal device sealsabout the recesses. Alternately, the release agent material may bepositioned in longitudinal strips between the tyvek and plastic layersprior to the heat sealing step, so that the heat seal is through therelease agent between the two layers of material. It is preferred,however, that the release agent material be applied directly to theTyvek layer.

A heat seal platen is applied to the webs to form the seals for adjacentpackages. The assembly is then advanced to a cutter mechanism which cutsthe pouches just below the transverse seal to form the bottom of onepackage and along the longitudinal seals, while ensuring that the topedge seals of the individual packages include the gripping tab formedfor each package which facilitates separation of the plastic layer fromthe Tyvek layer to open the pouch.

It will be thus seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained, andsince certain changes can be made in the above construction anddifferent embodiments of the invention could be made without departingfrom the scope thereof, it is intended that all matter contained in theabove description or shown in the accompanying drawing shall beinterpreted as illustrative and not in a limiting sense.

What is claimed is:
 1. A method for packaging a combined surgicalneedle-suture device upon a retainer base panel which comprises:a)slidably mounting a needle shield possessing a needle tip stop andparallel flanged sides upon the obverse side of a flat retainer basepanel possessing parallel lateral sides such that the flanged parallellateral sides of the needle shield make gripping contact with theparallel sides of the base panel; and, b) placing the needle componentof the combined surgical needle-suture device in contact with the needleshield such that the point of the needle is proximate to, or abuts, thestop.
 2. The method of claim 1 wherein before or after step (b), thefree end of the suture component of the combined surgical suture-needledevice is passed through an aperture on the base panel and the suturecomponent is attached to the obverse side of the base panel.
 3. Themethod of claim 2 wherein the suture component is placed within a coiledpassageway in contact with the obverse side of the base panel.
 4. Themethod of claim 3 wherein the suture component is drawn into thepassageway by a vacuum applied thereto.